Rhodia Fine Organics

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WASTE EFFICIENCY MEASURES AT SHASUN PHARMA
SOLUTIONS LTD. Envirowise Conference 5th
December 2007
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Dudley Site (Northumberland)
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Dudley Site Overview

• 42 Acre Site
• Process Development Laboratories
• Highly flexible Pilot Plant
• 3 Major Production Facilities D1, D1.5 D2
• 450 m³ cGMP reactor capacity
• Biological Waste Water Treatment Facility
• Successful FDA PAI January 2002
• Successful MHRA audit Nov 2005
• Successful FDA PAI January 2007
• Successful MHRA audit Oct 2007

Currently 263 employees
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Dudley Pilot Plant Overview

• 5 independent reactor bays
• 50 - 300 gallon scale
• Range of pressure filters, centrifuges and
  tray driers
• Glove box facilities for final product handling
• High temp fractionating unit 30 theoretical
  plates
• High vacuum WFE / SPE unit
• All operations to cGMP

All operations to cGMP
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Dudley Manufacturing Overview

• Range of intermediate (20) and API reactor
  trains (2)
• 300 3000 gallon scale
• Range of pressure filters, centrifuges and
  blender driers
• USP Purified water system and cleanroom
  facilities
• Low temperature (-40ºC) capability
• High vacuum WFE / SPE unit
• High temp fractionating unit 30 theoretical
  plates
• Grignard, organometalic, Friedel
• Craft and carbonylation capability
• Bulk Br2, Cl2, H2, and PCl3

All operations to cGMP
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Innovation

• Development of new technology
• Alternative delivery options
• Rapid process industrialisation
• Route selection / alternative suggestion
• Plant build and commissioning
• Development productivity - multi-reactors
• Manufacturing technology continuous processing
  

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Periodical Process Reviews

• Purpose to ensure that regular reviews are
  carried out to identify process improvements and
  waste minimisation opportunities. Four
  techniques
• Mass Balance
• Waste Auditing
• Process Improvement Plan
• BritestTM Tools

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Waste Auditing

• Aim to ensure that regular waste reviews are
  carried out for every process in routine
  manufacture.
• Setting it up to make it work
• Management support essential.
• Standard Operating Procedure (SOP) written to
  describe method.
• Standard report format set up.
• Participants trained in SOP.

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Waste Auditing

• Setting it up to make it work
• Included in annual objectives (Process
  Performance Group).
• Audit completion tracked monthly. Schedule
  published.
• Monthly update issued actions
  complete saved
• Each process is audited at least annually.

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Waste Auditing

• How we do a Waste Audit at SPSL
• Involve the right people Process Manager
  (audit leader) Production Coordinator Oper
  ator (shop floor) Waste Disposal
  Contractor Innocent Party / Stranger!
• Review the process, step-by-step. - Around a
  table (1st audit). - Walking the process on the
  plant (2nd audit).
• Identify and reduce / eliminate waste.

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Waste Auditing

• How we do a Waste Audit at SPSL
• understand what waste is!
• Waste streams arising from the process- solids
  in drums,- liquids in drums (Recovery, Cement
  fuel, Incineration),- aqueous effluent
  (Biological treatment plant),- losses to air.
• Raw materials put into the process- solvents
  (recycling or recovery opportunities)- reagents
  (reduce excesses)- catalysts- cheaper
  alternatives

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Waste Auditing

• How we do a Waste Audit at SPSL
• understand what waste is!
• Packaging (cheaper pack or re-use)- metal drums
  or plastic drums- fibreboard drums- IBCs
• Utilities- water- nitrogen- steam

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Waste Auditing

• How we do a Waste Audit at SPSL
• understand what waste is!
• Energy- electricity- Liquid Fuel Oil
• Time- operator time- analyst time- warehouse
  time- Time is money

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Waste Auditing
How we do a Waste Audit at SPSL The Toddler
Technique WHY? WHY? WHY? WHY?
WHY?
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Waste Auditing
How we do a Waste Audit at SPSL The Toddler
Technique in action Why do we run the scrubbers
on this process? To prevent air
emissions What air emissions? Well none
really, there are no acidic materials present,
the alcohol solvent is contained by condensation
(-15oC) and is harmless to the environment
anyway
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Waste Auditing
How we do a Waste Audit at SPSL The Toddler
Technique in action So why do we use the
scrubber? We always use a scrubber if its
available! We agreed not to use the scrubber
and to review scrubber use on our other processes
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Waste Auditing
How we do a Waste Audit at SPSL implement then
calculate and publish the savings Scrubber usage
review saved us (annually, 3 process stages) -
water (purchase disposal costs) 820 - 18
Caustic soda solution 105 - electricity
bill 1100 - Operator time for scrubber
operations ?? - Analyst time (caustic content
analysis) ?? Good News found that in majority
of processes we were using our scrubbers sensibly
efficiently.
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Waste Auditing
The Big Question WHY DO WE DO THIS AND IS THERE
A BETTER ALTERNATIVE?
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Process Improvement Plan (PIP)

• Aim to capture the improvement ideas /
  opportunities that have been identified for each
  process.
• Process Manager (Chemist) considers - current
  reaction conditions - reagents /
  proportions - solvent use - temperature
  pressure profiles - process wastes
• Sitting and thinking.
• Watching the process on the plant. Chatting to
  the operator and others.

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Process Improvement Plan (PIP)

• Lots of overlap with Waste Audit conclusions.
• Standard recording format.
• Monthly update issued ideas
  implemented saved
• PIP a live document, kept for every product.

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Waste Efficiency Examples

• Example 1 Process 0001
• Main plant manufacture permanent, ongoing
  production.
• Reaction quench solvent is an alcohol.
• Lab studies demonstrated that a cheaper alcohol
  works as well as the more expensive alcohol in
  current use.
• Yield, quality process time unaffected.
• Change made, annual saving 59k.

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Waste Efficiency Examples

• Example 2 Process 0001
• Main plant manufacture permanent, ongoing
  production.
• Reaction quench solvent volume reduced by 41.
• Annual reduction in solvent usage of 76,000 L.
• Equivalent reduction in volume of waste from
  process.
• Annual saving 13k.

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Waste Efficiency Examples

• Example 3 Process 0002
• Considered the disposal route for an acetone
  waste why Cement fuel?
• Original low volume of production meant recovery
  not viable.
• Reviewed volume of production had increased
  making recovery a viable option.
• Better use of a waste stream achieved. Annual
  saving 5,200.

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Waste Efficiency Examples

• Example 4 Process 0003
• Considered the disposal route for ester
  distillate waste stream why Cement fuel?
• Original low volume of production meant recovery
  not viable.
• Reviewed volume of production had increased
  making recovery a viable option.
• Better use of a waste stream achieved. Annual
  saving 9,500.

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Waste Efficiency Examples

• Example 5 Process 0004
• Relocation of a distillation operation.
• More efficient still, reduced LFO cost 6k /
  year.
• Transfer via hard pipe, no more drum usage or
  manual handling or forklift truck transfer
  between plants.
• Drum cost saving 13k / year.

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Waste Efficiency Examples

• Example 6 Project 0005
• Re-use of fibreboard drums to transport wet cake
  from filter to dryer (different areas).
• cGMP product so SOP introduced to cover
  operations and training carried out.
• Drum usage reduced by 35.
• Annual saving 908, being expanded to other
  processes.

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Examples of Waste Efficiency

• Example 7 - Project 0006 stage 2
• Each batch uses a precious metal on carbon
  catalyst in a coupling reaction generates one
  drum of solid waste (200 kg but containing 360g
  precious metal).
• Original route of disposal was incineration.
• Waste now repackaged for return to the catalyst
  manufacturer (for recovery of metal).
• We get paid, annual saving 7 k.

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Concluding Remarks

• At SPSL we have an ongoing commitment to Waste
  Efficiency Measures in all of its forms.
• In current year we have saved 111k to date.
• Annualised saving 132k.
• A project with no end (!)